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Completed

NCT Number: NCT05186727

Family History and Breast Cancer Education Trial

The overall goal of this study is to reduce breast cancer morbidity and mortality disparities among African American women by actively engaging family history as a tool to modify screening regimens and enhance communication between women and their providers. Therefore, this rationale is reflected the project title: "You cannot change your family history, but you can change what you do with it: A peer-based education program to reduce breast cancer risk in African American women"

This study will develop and test an educational curriculum that highlights the importance of knowing family history and sharing it with health care providers. The curriculum will include tools to gather family history and discuss it with providers to guide the delivery of care. The investigators will assess the effectiveness of the curriculum in group and one-on-one settings and when delivered by a Patient Ambassador (peer train-the trainer model) or a researcher.

The specific objectives of the study are to:

Obj. 1: Develop a CBPR-based curriculum- using a community based participatory research (CBPR) approach, that highlights the importance of family history as a risk factor for breast cancer that includes tools to collect family history information and discuss it with providers to enable a family history based screening regimen.

Obj. 2: Train Patient Ambassadors- Patient Ambassadors, women from the community who act as community messengers to deliver the curriculum.

Obj. 3: Pilot Implementation and Extensive Evaluation of the Curriculum- Assess two modes of delivery, group vs one-on-one, and Peer Ambassadors vs. a researcher.

Obj. 4: Dissemination- of the curricular products, implementation pilot results, and implementation guides for communities and practices- via publications and other channels in preparation for grant submits to enhance the program.

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Key information

Conditions

Genetic Predisposition to Disease Disease Attributes Disease Susceptibility Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

SUNY Buffalo

Buffalo, New York, 14203, United States

About this study

Women from underserved communities are eligible to participate in the educational workshop and the evaluation of the study. We aim to recruit 200 women; 50 randomized into each arm (researcher group, researcher one-on-one, Patient Ambassador group, Patient Ambassador one-on-one) of the evaluation. Participants will be recruited from community-based sources such as the Buffalo Research Registry, primary care practices, and word of mouth through Patient Voices Network, Our Curls, and other community-based organizations. It is anticipated that most of these women will be African American as recruitment will be geared toward predominately African American communities. A marketing flyer, available in e-mail or print format, will be developed to disseminate through the various community-based strategies. Women will be consented and randomized telephonically. Randomization without replacement will be used for every four women consented to ensure equal groups. The research associate will conduct the baseline assessment will be collected over the telephone to maintain the evaluation separate from the implementation of the curriculum. Curriculum content areas include: Breast health knowledge, Breast cancer knowledge, Family History Genetics, Breast Cancer Genetic Testing Methods, and how to collect family history information. Women randomized into the one-on-one phone interventions will be immediately linked to either the Patient Ambassador or researcher who will be administering the curriculum. An initial contact will be made for introductions, to describe the process and schedule four additional times for phone calls. One phone call will be made per week for four weeks. A packet of materials, that include curriculum handouts and supporting tools, will be sent to the participant for follow-up calls. The Patient Ambassador or professional will then follow up with each participant according to the arranged schedule. For participants randomized to the group sessions, 4 dates will be offered at the time of consent for an average of 12-13 participants at each group. Participants will be asked to choose one date. The same materials and tools will be given to the women at the beginning of the session. The curriculum will be delivered in a more didactic approach with time for group interaction and hands on activities. The sessions will be conducted via ZOOM. A fidelity checklist will be created that a member of the research team will complete for both group sessions and will spot check 20% or the on-on-one needs to complete to ensure completion of the full curriculum and protocols is adhered to. Once a month contacts will be made by the individual that delivered the curriculum as a retention strategy. Assessments are conducted immediately after the intervention and three months after the close of the education. These surveys will consist of the same measures included in the baseline and will add a measure about satisfaction with the curriculum, the facilitator, and the mode of delivery.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 40 years of age and older
  • Live in predominately African American communities (ZIP codes)

Exclusion criteria

  • No previous breast cancer diagnosis

Treatment and study plan

Family History education

Other

The education, developed in partnership with community partners, intends to assist women to collect family history of breast cancer and share it with their providers.

Patient Ambassador

Other

The support of a Patient Ambassador in addition to the education is also tested.

Primary outcomes

  1. Change in Knowledge of Genetic Screening for Breast Cancer

    Time frame: Baseline

    The breast cancer genetic counseling knowledge questionnaire will be used to assess knowledge. This tool was validated by nurses, genetic counselors, and a group of employees.

  2. Change in Knowledge of Genetic Screening for Breast Cancer

    Time frame: 1 week Post Intervention

    The breast cancer genetic counseling knowledge questionnaire will be used to assess knowledge. This tool was validated by nurses, genetic counselors, and a group of employees.

  3. Change in Knowledge of Genetic Screening for Breast Cancer

    Time frame: 3 Months Post Intervention

    The breast cancer genetic counseling knowledge questionnaire will be used to assess knowledge. This tool was validated by nurses, genetic counselors, and a group of employees.

  4. Change intention to be screened and to gather family history and share with providers

    Time frame: Baseline

    Other items to be assessed will include attitude towards screening and family history, intent to be screened, intent to gather family history, and intent to discuss family history of breast cancer with their providers. The PRECEDE-PROCEED model will serve as a framework for the evaluation of intent to change. This model serves as a method to measure the socioecological, educational, and social epidemiological aspects of behavior change.

  5. Change intention to be screened and to gather family history and share with providers

    Time frame: 1 week Post Intervention

    Other items to be assessed will include attitude towards screening and family history, intent to be screened, intent to gather family history, and intent to discuss family history of breast cancer with their providers. The PRECEDE-PROCEED model will serve as a framework for the evaluation of intent to change. This model serves as a method to measure the socioecological, educational, and social epidemiological aspects of behavior change.

  6. Change intention to be screened and to gather family history and share with providers

    Time frame: 3 Months Post Intervention

    Other items to be assessed will include attitude towards screening and family history, intent to be screened, intent to gather family history, and intent to discuss family history of breast cancer with their providers. The PRECEDE-PROCEED model will serve as a framework for the evaluation of intent to change. This model serves as a method to measure the socioecological, educational, and social epidemiological aspects of behavior change.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

You Cannot Change Your Family History, But You Can Change What You do With it: A Peer-based Education Program to Reduce Breast Cancer Risk in African American Women

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2022
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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